Study on the Effects of Etrasimod Arginine for Patients with Moderate to Severe Crohn’s Disease

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What is this study about?

This clinical trial is focused on studying Crohn’s Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study is testing a medication called Etrasimod Arginine, which is taken as a tablet. The purpose of the study is to evaluate the safety and effectiveness of this medication as a treatment for people with moderately to severely active Crohn’s Disease.

Participants in the study will be randomly assigned to receive either the Etrasimod Arginine tablet or a placebo. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, with regular check-ins to monitor the participants’ health and the effects of the treatment.

The study aims to determine the best dose of Etrasimod Arginine for treating Crohn’s Disease by comparing the effects of two different doses. Researchers will look at how well the medication works in reducing the symptoms of the disease and how safe it is for the participants. The ultimate goal is to find a dose that is both effective and safe for long-term use in managing Crohn’s Disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of Crohn’s disease, and previous treatment history.

Written informed consent is required, and the ability to comply with the study schedule is assessed.

2 induction therapy

The induction phase involves taking etrasimod arginine tablets orally. The dosage and frequency are determined by the study protocol.

This phase aims to evaluate the initial response to the medication over a specified period, typically up to 14 weeks.

3 assessment of response

During the induction phase, the response to treatment is assessed through clinical evaluations and endoscopic examinations.

The primary goal is to observe any endoscopic response and clinical remission, which are key indicators of the medication’s effectiveness.

4 maintenance therapy

If the induction therapy is successful, the patient may continue to the maintenance phase, which involves ongoing administration of etrasimod arginine tablets.

This phase is designed to maintain the therapeutic benefits achieved during induction and is evaluated over a longer period, potentially up to 52 weeks.

5 ongoing monitoring

Throughout the trial, regular monitoring is conducted to ensure safety and track the progress of the treatment.

This includes periodic clinical assessments, laboratory tests, and endoscopic evaluations to monitor the disease activity and any side effects.

6 completion of the trial

Upon completion of the trial, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

The results contribute to the understanding of etrasimod arginine as a potential therapy for Crohn’s disease.

Who Can Join the Study?

  • Participants must be between 18 and 80 years old.
  • Participants must be able to provide written consent and follow the study schedule.
  • Participants must have been diagnosed with Crohn’s Disease for at least 3 months, affecting the ileum (part of the small intestine) and/or colon (part of the large intestine). This diagnosis can be confirmed by past medical tests.
  • Participants must have moderately to severely active Crohn’s Disease, which means a specific score on the Crohn’s Disease Activity Index (CDAI) between 220 and 450, along with certain symptoms like abdominal pain or frequent loose stools, and a specific score on an endoscopic test called SES-CD.
  • Participants must have previously tried and not responded well, lost response, or could not tolerate at least one of the following treatments for Crohn’s Disease: oral corticosteroids, immunosuppressants, TNFα antagonists, integrin receptor antagonists, or interleukin-12/23 antagonists.
  • Females who can become pregnant must not be pregnant.
  • Females who can become pregnant and males must agree to use contraception during the study.

Who Cannot Join the Study?

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an active infection that requires treatment.
  • Patients who have been diagnosed with cancer in the past five years, except for certain types of skin cancer.
  • Patients who have a history of heart problems, such as heart attack or heart failure.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have liver or kidney disease.
  • Patients who have a history of blood clotting disorders.
  • Patients who have a history of mental health disorders that are not well controlled.
  • Patients who are unable to follow the study procedures or attend study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria
Medizinische Universitaet Innsbruck Innsbruck Austria
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
University Hospital Of Clermont-Ferrand Clermont Ferrand France
CHU Grenoble Alpes La Tronche France
Specjalistyczne Gabinety Lekarskie Landa Cracow Poland

Other Sites

Site Name City Country Status
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Ospedale San Raffaele S.r.l. Milan Italy
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nice Nice France
Az Maria Middelares Gent Gent Belgium
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Ugadfkisjt Mtlszjiywvyw Htfifdhc Fbe Audkrn Tsykigvsf Aam Evogjflvf Mggpodkm N I Pggeaer Sofia Bulgaria
Csgypc Hqlqjnraics Dpsmlfcbwuiii Vmsbzv La Roche sur Yon France
Edseqnlzstsf Spwz Athens Greece
Dudztyinzyybeutxbeciruf cyhtfn “ecnbqzupyqseorq Ebpq Sofia Bulgaria
Fzwwundpyj Ikhae Pegbqhemlaz Syq Mkinkc Pavia Italy
Aubinyaxo Ufq Amsterdam The Netherlands
Uydtgmucyqbf Munqfjg Cephfea Uqoydff Utrecht The Netherlands
Ckiitl Hnwyoutqzkl Ujrttpsnhgpip Dx Mftsxafninh Montpellier France
Aeqrwsu Uqspbyoqit Hprwific Aalborg Denmark
Cxdo Dw Nwgjn Vandoeuvre Les Nancy France
Cnyzci Hrfculjwlxb Uuhhrgocnlaed Aliqhj Pezmbwpm Amiens France
Utmtrfxfsobi Zuvkoetata Ghby Gent Belgium
Uimkcanzocudfiktrdzky Syunpdajsyqowdksyl Agq Kiel Germany
Aumsxqsz Zsujzwoqhn Dtfok Roeselare Belgium
Fohbkszoz Pkwb Ll Izcfivffhtdcd Bjpreskuk Dyo Hwgksmve Ubvgrxvrleewj Ly Piv Madrid Spain
Crrvyr Hifcxvihbvd Urfjycnnpptvm Dolplw Gdkdmiy Sfcagkxojppxmhjkxnacsjovkx Namur Belgium
Ulwgnskukb Gdstgai Hvzltciw Of Hmpyeztgz Heraklion Greece
Unbjkxzmndxqsfdrypkrt Lbgrlxy Aew Leipzig Germany
Eseloqs sjltnu Kosice Slovakia
Kri Zabrhq Zagreb Croatia
Bjrhyjvtwh Syi z ofwq sotna Warsaw Poland
Girkpqlypemypmaom Olefjdyllts Kassel Germany
Iitlzmkh dt Cnpoprjqzfyc Hsksrgrmziw Uufgeuscbnehj dn Smtqz Eitwslc (sdoqrqn Saint Priest En Jarez France
Aqqjsos Sce z ojip Svpv Lodz Poland
Tqfqxoac Seb z ociw Piotrkow Trybunalski Poland
Iyxux Obolypgh Sszdu Croac Dtu Ckaiasra Negrar di Valpolicella Italy
Awbxfftnxy Fiqdgpipvyd Dipptufx Kigrrlsf gfpal Frankfurt Germany
Cxhoimu Zeqguxd Mmw Warsaw Poland
Acmbdto Ogtxfkyuunp Pby Lhynehbupkzldrtmk Cfoqrdcrge Catania Italy
Hxybbepvoqezdasocufaotdz Hf sqwyuy Hradec Kralove Czechia
Kp Mcgflzjlkl snmmx s rdsx Nitra Slovakia
Hdxumuhf Gyynjaj Dg Trlxbkzaj Tomelloso Spain
Cyjilzq Mzansnro Mjead Srk z otmg Rzeszow Poland
Cjpaqq Rqrsnmve Csaqndwx Du Vhfabp Sibruy Verona Italy
Cizx Skztfjnn Dpdsr Shinhlflmy San Giovanni Rotondo Italy
Pilcnshvhik symjfe Olomouc Czechia
Uqomqjubxqyhypjzuzila Bekfbqvuhaz aa drf Hilye Gssc Brandenburg An Der Havel Germany
Hjjtqeex Hvbzswcb Hvidovre Denmark
Ubutdzkwzognwobufoadm Ahrgxtlh Augsburg Germany
Ucxmupxehr Mhina Gzkekki Oy Cwahdgpiq Catanzaro Italy
Dpgrgi Mugtpp Kjcudnkp snohp Swidnica Poland
Kdaindqcbndetmzfd Vaagqqsad Sgxex Byslpne Kykfgp Tatabanya Hungary
Abkln sgcycc Bardejov Slovakia
Hbrxrbrzbnjys Fwccfhzefsqaudsftq fwjb cxgfjccdc ekgfjwaafclta Dwnyqhtljdwlmcyr Hcsxgw exsg Hamburg Germany
Spsrugo Sap z oewu sxlyl Poznan Poland
Ih Caenrg Scx z oyqf Lodz Poland
Eu Hqsygdjt Uahbvslcoidxk Db Gttm Cgbgtvs Dda Nptanx Las Palmas De Gran Canaria Spain
Tjetskrm Szy z ozbl Poznan Poland
Puryzhxncgb Bteqfi dnleap Osijek Croatia
Gclbpq Ls sjxhsr Presov Slovakia
Ghenxx Jlcc sqkkyq Klatovy Czechia
Prtvbrcm Mgfbdeockvb Csonjhd Kobp Budapest Hungary
Wdr Wzfbuq Irm Pojpr Pnpalojx Koewemg Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
14.07.2021
Belgium Belgium
Not recruiting
14.07.2021
Bulgaria Bulgaria
Not recruiting
14.07.2021
Croatia Croatia
Not recruiting
14.07.2021
Czechia Czechia
Not recruiting
14.07.2021
Denmark Denmark
Not recruiting
14.07.2021
France France
Not recruiting
14.07.2021
Germany Germany
Not recruiting
14.07.2021
Greece Greece
Not recruiting
14.07.2021
Hungary Hungary
Not recruiting
14.07.2021
Italy Italy
Not recruiting
14.07.2021
Poland Poland
Not recruiting
14.07.2021
Slovakia Slovakia
Not recruiting
14.07.2021
Spain Spain
Not recruiting
14.07.2021
The Netherlands The Netherlands
Not recruiting
14.07.2021

Trial locations

Investigated Drugs:

Etrasimod is an oral medication being studied for its potential to help people with moderately to severely active Crohn’s disease. The trial aims to evaluate how safe and effective etrasimod is when used as an initial treatment. The study also seeks to understand how different doses of etrasimod work in comparison to each other. The goal is to find the most effective and safe dose for further development.

Investigated Diseases:

Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The exact cause of Crohn’s Disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The progression of the disease can vary greatly among individuals, with some experiencing mild symptoms and others facing more severe challenges.

Trial ID:
2024-513569-38-00
Protocol code:
C5041006
Trial Phase:
Therapeutic use (Phase IV)

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